Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993042
• Other study ID #: RAGT-GAP
• Status: Completed
• Phase: N/A
• First received: December 6, 2016
• Last updated: March 8, 2018
• Start date: December 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by repeating a normal gait pattern with high intensity. This study is a feasibility study to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson 's disease.

Description:

Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.

Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved the recovery of independent gait after stroke compared with conventional rehabilitation therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been reported to improve walking speed and walking endurance compared to conventional physical therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has been reported that in patients with Parkinson's disease with balance impairment, robot-assisted gait training can improve balance disorder compared with physical therapy, and gait freezing has improved in some small-scale patients. However, studies on the effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and the mechanism of the effect has not been elucidated. In particular, the effect on gait automaticity, which is a characteristic of Parkinson 's disease, has not been studied. Therefore, this pilot study is aimed to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically confirmed patients with idiopathic Parkinson's disease

• Hoehn & Yahr stage 2.5 or 3 patients

• Patients with a Mini-Mental Status Examination (MMSE) score of 24 or higher

Exclusion Criteria:

• Patients with severe dyskinesia or on-off fluctuations due to medication

• Patients who need to change drugs during the study period

• Patients with sensory abnormalities of the lower limb

• Patients with vestibular disease or paroxismal vertigo

• Patients with other neurological or orthopedic disease involving legs, or severe cardiovascular diseases

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

Device:
• Robot-assisted gait training
Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of dual-task interference: cognitive	(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test	at 4 weeks
Primary	Percentage of dual-task interference: physical	(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test	at 4 weeks
Secondary	10 meter walk test (sec): single, cognitive dual-task, physical dual-task		baseline, at 4 weeks, at 8 weeks
Secondary	Berg balance scale		baseline, at 4 weeks, at 8 weeks
Secondary	Korean version of the Falls Efficacy Scale-International		baseline, at 4 weeks, at 8 weeks
Secondary	Step length	Gait analysis using IMU sensors	baseline, at 4 weeks, at 8 weeks
Secondary	Step width	Gait analysis using IMU sensors	baseline, at 4 weeks, at 8 weeks
Secondary	Cadence	Gait analysis using IMU sensors	baseline, at 4 weeks, at 8 weeks
Secondary	Vertical displacement	Gait analysis using IMU sensors	baseline, at 4 weeks, at 8 weeks
Secondary	Percentage of dual-task interference: cognitive	(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test	baseline, at 8 weeks
Secondary	Percentage of dual-task interference: physical	(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test	baseline, at 8 weeks